SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL

SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL is an FDA 510(k)-cleared medical device (K821027) manufactured by Shiley, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 2, 1982. Regulation: 8.